|GUIDELINE AND CONSENSUS
|Year : 2020 | Volume
| Issue : 2 | Page : 71-80
Chinese expert consensus on transcatheter aortic valve replacement (2020 Update)
|Date of Submission||13-Jun-2020|
|Date of Acceptance||15-Jun-2020|
|Date of Web Publication||30-Jun-2020|
Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
. Chinese expert consensus on transcatheter aortic valve replacement (2020 Update). Cardiol Plus 2020;5:71-80
Structural Heart Disease Professional Committee, Cardiovascular Branch, Chinese Physicians′ Association
| Introduction|| |
Transcatheter aortic valve replacement (TAVR), also known as transcatheter aortic valve implantation, refers to the installation of an artificial stented valve into a catheter and its delivery into the aortic valve position to replace the function of the aortic valve. Since the first successful case in 2002, TAVR has become the first-line treatment option for aortic stenosis (AS) in the elderly. European and American countries have published and updated TAVR guiding documents.,,,, The development of TAVR in China is relatively slow, and the first case of TAVR was performed on October 3, 2010. However, TAVR has entered a stage of rapid and comprehensive development in China since the 2017 approval of two domestic valves. The Structural Heart Disease Professional Committee, Cardiovascular Branch, Chinese Physicians' Association issued the first TAVR guiding document, “Chinese expert consensus on transcatheter aortic valve replacement” at the end of 2015. The document has played a positive role in guiding the early promotion of TAVR in China. Since the publication of the document, significant progress has been made in the devices, clinical research, and application experiences in TAVR. Therefore, this expert consensus needs to be updated to update the knowledge on TAVR and promote the healthy, standardized, and rapid development of TAVR in China.
| Epidemiological Characteristics of Aortic Valve Disease|| |
In Western countries, AS is a common heart disease in the elderly, and its incidence increases with age. About 2% of the population over 65 years and 4% over 85 years have been reported to suffer from AS., There are no exact epidemiological data on AS in China. A single-center echocardiography database analysis indicated that the incidence of AS in China may be lower than that in Western countries. TAVR candidates in China have a higher proportion of bicuspid aortic valve (BAV), more severe calcification, more aortic regurgitation (AR), a higher proportion of rheumatic etiology, and a smaller femoral artery diameter than those in Western countries.,,,, In addition, in the constitution of the anatomical subtypes of patients with BAV undergoing TAVR, the Type 0 (non-ridge type) in Chinese patients is higher than that in patients from Western countries. Although the proportion of BAV in TAVR candidates in China is relatively higher, a single-center study showed that the proportion in Chinese patients with severe AS might be similar to that in patients from Western countries (about 50% in patients aged 60–80 years and about 20% in those over 80 years). Another large sample population analysis based on an echocardiography database showed that the incidence and complication rate of BAV in China were similar to those in the Western population.
| Current Status of Transcatheter Aortic Valve Replacement|| |
Based on the results of the Partner 2 and SURTAVI trials, the European and American guidelines have recommended patients at extremely high, high, and intermediate risk for surgery as an indication for TAVR. Recently, the PARTNER 3 (using balloon-expanding valve Sapien 3) and Evolut Low-Risk Trial (using self-expanding valve Evolut R) studies showed that in patients at low risk for surgery, TAVR was superior to or not inferior to surgery. Based on these two trials, in 2019, the US and European governments approved the Sapien 3 and Evolut R transcatheter heart valves for use in low-risk patients. Until 2019, more than a dozen types of TAVR valves were approved for clinical application outside China. Over 400000 cases of TAVR have been performed globally. In May 2017, two domestic valves (Venus-A and J-Valve) were approved in China. In July 2019, another domestic valve (VitaFlow) was approved. Venus-A and VitaFlow are self-expanding valves implanted through the peripheral artery. The J-Valve is a transapical self-expanding valve that can be used to treat AS and AR. The approval of domestic valves promoted the rapid development of TAVR in China.
By the end of 2019, >20 provinces or municipalities and 200 hospitals in China had completed over 4000 TAVR procedures, including >2600 completed in 2019. China has accumulated its own experience in TAVR. The experience of several major centers in China reveals that there is no significant difference in the efficacy of TAVR between the BAV and tricuspid aortic valve (TAV).,,, The J-Valve transcatheter aortic valves have anchoring equipment and are suitable for treating AR patients. China has gained much experience in the area of TAVR for patients with AR. There are a small number of centers that can independently perform the TAVR procedure in China; however, there is still a large gap in TAVR experience between China and European or American countries. Clinical characteristics of Chinese patients are also different from those of patients in other countries. Therefore, overseas guiding documents cannot be completely applicable for the clinical practices in China. Thus, it is necessary to formulate guiding documents that are suitable for China's national conditions.
| Transcatheter Aortic Valve Replacement Indications|| |
TAVR indications listed in the 2017 European valvular heart disease management guidelines are as follows: patients with symptomatic severe AS who are not suitable for surgery (I, B); patients with a high surgical risk, defined as the Society of Thoracic Surgery (STS) score or the European Cardiac Surgery score second version (EuroSCORE II) >4%; and patients having other risk factors, such as weakness, porcelain aorta, and prior chest radiotherapy, especially elderly patients who are suitable for femoral artery access. TAVR indications listed in the American valvular heart disease management guidelines of 2017 are as follows: AS patients with contraindications or high risk for surgery, who are expected to survive for >12 months (I, A); and severe AS patients at intermediate risk for surgery (IIa, B-R). Although the relevant government departments in the United States and Europe have approved the Sapien 3 and Evolut R transcatheter aortic valves for low surgical risk patients, the European and American guidelines do not recommend TAVR for these patients. The medical development levels in different regions of China are unbalanced. There is a difference in the knowledge of high-risk and contraindications for surgery. Compared with European or American countries, both patients and doctors are more inclined to select conservative treatment rather than surgery in China. Combining the national conditions and research progress in China and other countries, we suggest the following TAVR indications and contraindications:
(1) Severe AS. Echocardiography shows that the blood flow velocity across the aortic valve is >4 m/s, the mean transvalvular pressure gradient is >40 mmHg (1 mmHg = 0.133 KPa), the aortic valve orifice area is <1 cm2, or the effective aortic valve orifice area index is <0.5 cm2/m2. Patients with low blood flow and output were assessed using the dobutamine stress test, Doppler echocardiography, or other imaging methods and identified as severe AS. (2) Having symptoms such as shortness of breath, chest pain, and syncope. The New York Heart Association (NYHA) cardiac function class is above two grades, and the symptoms were definitely caused by AS. (3) Suitable anatomy for TAVR, including calcification severity of the native valve, aortic annulus diameter, aortic sinus diameter and height, coronary ostia, and peripheral artery diameter. (4) The life expectancy expected to be >12 months after rectifying AS. (5) TAV. (6) Extremely high-risk for surgery (without age requirement), or intermediate- or high-risk for surgery and over 70 years of age. Surgical risk assessment is based on the 2014 American valvular heart disease management guidelines. Those who meet all the above conditions are considered to have absolute indications for TAVR. Furthermore, surgical bioprosthetic valve degeneration is also an absolute indication for TAVR.
(1) Meeting terms 1–5 above, surgical low-risk (STS score <4%), and over 70 years. (2) Meeting terms 1, 2, 3, 4, and 6 above, and BAV, or meeting the above terms, BAV 1, low surgical risk, and over 70 years. TAVR can be performed under these two conditions in experienced centers (defined as completing >20 cases of TAVR per year) or with the help of an experienced team (defined as completing more than 20 cases of TAVR per year). (3) For patients meeting terms 1, 2, 3, and 4 above and aged 60–70 years (BAV or TAV), the heart team judges suitability for TAVR based on the surgical risk and patient's wish. The J-Valve valve is effective for pure AR through the transapical approach. This consensus is mainly focused on TAVR with vascular access. Therefore, related content about transapical TAVR using the J-valve are not mentioned. Currently, some centers in China and other countries use self-expanding valves to perform TAVR for the treatment of pure AR, but there is still insufficient clinical evidence.
Contraindications to TAVR include left ventricular thrombus, left ventricular outflow tract obstruction, unsuitable access, or aortic root anatomy for TAVR (such as the high risk of coronary artery occlusion), and short life expectancy after AS correction (<12 months).
| Preoperative Screening|| |
Preoperative screening for TAVR includes clinical assessment and imaging evaluation. Clinical assessment includes determining (1) whether valve replacement is needed, including the expected benefit of TAVR; (2) whether there is a surgical risk; and (3) whether there is a contraindication of TAVR. Imaging evaluation is the focus of preoperative evaluation for TAVR suitability, including the native aortic valve, aortic annulus, aorta, coronary and peripheral artery anatomy, and the size of the stented valve and includes the following techniques: (1) Transthoracic echocardiography (TTE) or transesophageal echocardiography (TEE). Cardiac morphology and function, valvular function and anatomy, and aortic root anatomy can be assessed by TTE or TEE. Echocardiography can be used as the main method of preoperative anatomical evaluation of the aortic root for patients who cannot tolerate computed tomography (CT) examination. Most patients have an elliptically shaped aortic annulus, and routine two-dimensional echocardiography is not accurate enough to measure the annulus from a single section. Three-dimensional echocardiography can make up for this defect. (2) Multislice computed tomography (MSCT). MSCT is currently one of the most important methods of TAVR imaging evaluation and is the main basis for judging patient suitability for TAVR and artificial valve size choice. We can observe the valve shape and evaluate the thickness of the valve, severity of calcification, and valve volume at the aortic root. We can measure the circumference and area of the annulus in the annulus plane and then calculate the inner diameter of the annulus to provide a basis for the selection of valve types and sizes and to assess the risk of postoperative paravalvular leakage (PVL). Further, MSCT can be used to assess the height of the coronary Ostia, predict the risk of coronary artery occlusion, and evaluate the degree of coronary artery disease. Furthermore, MSCT can also be used to assess the diameter of the peripheral artery. (3) Angiography. Aortic root angiography is not accurate enough for the measurement of the aortic annulus, aortic diameter, and coronary Ostia height. It is rarely used before TAVR. The abdominal aorta angiography can be used to assess the diameter of approaching vessels. Coronary angiography can be used to accurately assess the degree of coronary artery stenosis.
| Operative Specifications and Postoperative Antithrombotic Therapy|| |
Facilities and staff
It is suggested that TAVR be performed in a modified cardiac catheterization room or a hybrid operation room, and a multidisciplinary heart team should be established. The specific requirements are given in the guidelines for the Chinese expert consensus on the construction and operation of a TAVR team.
Key points of procedure
TAVR is recommended under general anesthesia and guided using digital subtraction angiography (DSA) in the center in the initial stage. Inexperienced centers, if a TAVR is predicted not to be difficult and the risk of surgery for the patient is not high, it is also feasible to choose minimalist TAVR under local anesthesia combined with sedation and without TEE guidance., As the vast majority of patients in China currently use self-expanding valves, the key points of the procedure are described as follows:
Establishment of vascular access
The femoral artery in the opposite side of the valvular access is punctured, and an artery sheath is inserted. A pigtail catheter is placed to the root of the aorta through its sheath for pressure measurement and angiography. A temporary pacemaker catheter is placed through a vein to the right ventricular apex. Angiography is performed to reveal the abdominal aorta or its main artery branches (main pathway) through the contralateral femoral artery (accessory pathway). Percutaneous puncture of the femoral artery is performed guided by DSA. The puncture needle entry point should be in the middle part of the femoral artery and upon the femoral artery branch. After the successful puncture, artery suture devices are placed. Vascular access can also be established by incising the subcutaneous tissue and then separating and puncturing the femoral artery. A 16–22 F introduced sheath is slowly advanced to the abdominal artery under the support and guidance of an extra-stiff wire. If the bilateral femoral arteries cannot be used as the diameter of the aorta, other access such as the common carotid artery and apex should be chosen.
Placement of the wires into the left ventricle
A straight head guidewire or a straight head hydrophilic coating guidewire is usually used for crossing the aortic valve. The supporting catheter is generally a 6 F Amplatzer L left coronary artery angiography catheter. After crossing the valve, the guiding catheter is also placed into the left ventricle and exchanged for the pigtail catheter. The left ventricular pressure is measured. An extra stiff wire is then inserted into the left ventricle through the pigtail catheter. The tip of the extra stiff wire end should be molded into a circle to increase the contact area with the left ventricle and to support the balloon and the valve delivery system.
Balloon dilation should be performed under right ventricular pacing. The frequency of pacing should be so fast that systolic blood pressure is <60 mmHg (1 mmHg = 0.133 kPa) and pulse pressure is <20 mmHg, which is usually 180–220 bpm. When the blood pressure reaches the target blood pressure after pacing, the balloon should be inflated and deflated quickly, and then pacing should be stopped. Balloon filling and emptying should be fast, and the total pacing time should be <15 s to avoid serious complications caused by prolonged hypoperfusion. Preoperative balloon dilation is performed to facilitate the crossing of the delivery system through the aortic valve and to stabilize hemodynamics. It can also assist in the selection of valve size and predict the risk of occlusions of the coronary artery. Different centers have different experiences in selecting balloon diameter, but the diameter of the balloon should not exceed that of the native aortic annulus.
Before the valve is released, the pigtail catheter delivered by the accessory road should be placed at the lowest point of the noncoronary cusp (NCC) as a reference point. The angle of DSA projection is adjusted to align the lowest points of the three aortic sinuses in the same plane. Preoperative MSCT can provide an angle for this. The optimal depth after valve release is 0–6 mm. Because the valve will move downward in most cases during the release, the initial release depth is slightly higher than the final targeted depth. During the releasing process, the depth of the valve should be adjusted according to the movement of the valves and can be confirmed according to the position of the pigtail catheter, bulk calcification of the native valve, or repeated angiography. The depth of the valve can be adjusted by the push or pull the delivery system, or extra stiff wire. The release process of the valve should be slow. The valve stent is easily shifted from the closing state to the anchoring state, which can be mitigated by rapid pacing (general frequency of 120–150 bpm, pacing time 10–20 s), reducing the possibility of valve displacement. If the second-generation retrievable valve is used and the valve position or valve size is not satisfactory, the valve can be retrieved and released. Immediately following implantation, echocardiography (TTE or TEE), aortography, and hemodynamics (including valve depth, valve shape, transvalvular gradient, PVL, coronary artery occlusion, and conduction block) should also be routinely performed. Severe paravalvular regurgitation and under deployment of the prosthesis may respond to postoperative balloon valvuloplasty.
Vascular approach management
For percutaneous transfemoral access, angiography of the femoral artery through the contralateral femoral artery is recommended before sheath removal to avoid access site-related complications. Surgical sutures or percutaneous vascular closure with ProGlide™ and Prostar™ XL could be used.
The key points of the procedure with balloon-expanding valves (Edward Sapien series) are similar to those of the procedure with self-expanding valves, except for the deployment. Prosthesis positioning in TAVR with balloon-expanding valves represents a crucial aspect for procedure success due to short valve stents. Optimal positions can be achieved guided by angiography and TEE. A pigtail catheter is typically placed in the right coronary cusp (RCC). The operator draws an imaginary line to mark the RCC in the middle of the left coronary cusp and the noncoronary cusp. Once optimal position is confirmed, the balloon-expanding valve is deployed under rapid ventricular pacing, accompanied by a drop in systolic pressure to <50 mmHg and a pulse pressure <10 mmHg.
Postoperative antithrombotic therapy
In general, individual antithrombotic therapy should be administered. The current standard antithrombotic therapy after TAVR is oral clopidogrel (75 mg daily) for 3–6 months with lifelong oral aspirin (75 mg to 100 mg daily). Patients with chronic atrial fibrillation (AF) or other indications for long-term anticoagulation treatment should receive anticoagulation therapy.,
| Prevention and Treatment of Complications|| |
The Valve Academic Research Consortium-2 consensus manuscript was published in 2012 with the goal of achieving consensus for standardizing definitions for single and composite clinical endpoints and consistency in reporting clinical outcomes of patients who would have undergone TAVR.
Conduction disturbances and arrhythmias
New-onset left bundle branch block (LBBB) and atrioventricular (AV) block requiring permanent pacemaker implantation (PPM) are common complications. The incidence of other complications decreases with the improvement of new generation devices, except for conduction disturbance. The incidence of new-onset LBBB with the first-generation valve was about 25%. Self-expanding valves were associated with a higher rate of new-onset LBBB than the balloon-expanding valves (18%–65% vs. 4%–30%, respectively). The incidence of PPM after TAVR was 13%. The incidence of new PPMs after the implantation of the self-expanding valve was five times higher than that after the implantation of the balloon-expanding valve (25%–28% vs. 5%–7%, respectively). Most of the atrioventricular block requiring PPM occurred within 24 hours after TAVR. However, 30% of new PPM occurred over 48 hours after TAVR. Moreover, some patients even received a new PPM in 1–6 months after TAVR. Positive predictors of PPM were the right bundle branch block (RBBB), first-degree atrioventricular block, self-expanding valve, deep valve location, oversize protheses, large size of balloon, the length of the interventricular septum, and calcification volume of the non-coronary cusp (NCC). A deeper implantation position of the prosthesis (>6 mm), large valve size, self-expanding valve, and pre-existing RBBB are associated with a greater risk of PPM. On the other hand, small balloon aortic valvuloplasty reduces the need for PPM after TAVR. For patients without conduction disorders and pre-existing RBBB, temporary pacing electrodes can be removed immediately after the procedure, and continuous electrocardiographic monitoring is required in 24 h after the procedure. For patients with pre-existing RBBB or post-procedure conduction disorders, the temporary pacemaker electrode should be kept in for 24 h, and further evaluation is needed. Permanent pacemaker implantation is recommended for patients with the high or complete atrioventricular block in 48 h after the procedure.
Paravalvular leakage (PVL) is a common complication after TAVR with the first-generation valves. The incidences of moderate PVL were 16% for the self-expandable valve (CoreValve) and 9.1% for the balloon-expandable valve (Sapien). An improved outcome in terms of lower PVL-rates is observed with the use of a new generation device. More than moderate PVL is associated with a higher late mortality rate. PVL is generally caused by the small size of the valves, severe calcification or a large calcified mass, and a deep implantation site for the prosthesis. TEE, TTE, angiography, and direct hemodynamic measurements (using the AR index) can all assist with identifying the severity of PVL. It is advisable to perform post balloon dilatation (under expansion of the prosthesis) or implant a new valve (very low or high implants) or a new occlude device in case of more than moderate PVL. A surgical procedure may be required for serious cases. Heavy, irregular calcific deposits within the annular area and incorrectly located and sized prostheses may respond to more and moderate PVL.
Coronary artery occlusion
Coronary occlusion is a relatively rare (0.66%) but fatal complication of TAVR. Patients with low coronary heights were not candidate for TAVR. In these patients, particularly in those with narrow sinuses and/or bulky aortic leafi‚ets, the coronary artery ostia are covered by the opening native leafi‚ets after TAVR. Besides, the skirt of the device could also cause coronary artery occlusion if the valve is highly implanted. Preoperative CT evaluation should be considered: valvular condition, anatomy of the aortic sinus, and prothesis characteristics are shown in [Table 1]. It is necessary to select strictly. Balloon valvuloplasty should be performed with a balloon size similar to the expected TAVR valve size while simultaneously performing root aortography to assess the movement of the leafi‚ets with respect to the coronary artery Ostia. Strategies should be discussed for high-risk patients with coronary artery occlusion. These include: (1) choosing a small size valve and deep position, but the incidence of PVL may increase; (2) coronary artery protection strategy, including the placement of wire, balloon, or stent in the coronary artery; and (3) emergency coronary artery intervention or coronary artery bypass grafting may be an option.
|Table 1: Risk factors for coronary artery occlusion after transcatheter aortic valve replacement|
Click here to view
The dominant mechanism of stroke appears to be the embolization of calcific material as a consequence of traumatic injury to the diseased valve leaflets. The incidence of clinically symptomatic stroke is 2%–3%. The incidence of ischemic injury detected using cranial magnetic resonance imaging was 80%–90%. Severely ill patients with multiple comorbidities may be at an increased risk of cerebral embolism. Additional risk factors include damage caused by delivery catheters, rapid pacing, and repeated manipulation (retrieving, repositioning) of the diseased valve. Reducing the risk of cerebral embolism has been achieved with minimal manipulation. The feasibility of cerebral embolic protection has been demonstrated and is currently under investigation. Input from a neurologist may also be helpful in select situations.
Local vascular complications mainly include dissection, occlusion, rupture, and bleeding of the access vessels such as the femoral and iliac arteries and the abdominal aorta. The incidence rate used to be up to 16.7%. However, with the application of the 18 F and below the delivery system, the incidence of complications has been reduced to 4.2%. Elderly patients, especially those with multiple complications such as hypertension, chronic renal insufficiency, diabetes, and hereditary hypercholesterolemia, are prone to vascular stenosis, atheromatous plaque, calcification, and excessive distortion, which may lead to vascular complications. Preoperative MSCT should be used to comprehensively and carefully evaluate access vessels to avoid the selection of too small or too twisted entry vessels and avoid rough operation. Once vascular complications occur, a peripheral vascular balloon and peripheral covered stent graft can be used, and vascular surgery should be performed if necessary.
Cardiac tamponade incidence is 1%–2%. To reduce the occurrence of this complication, the end of extra-tiff guidewire should be molded into a circle shape, and the extra-stiff guidewire should be fixed during balloon dilatation and advancing of delivery system. During the step using the straight head to enter the left ventricle, excessive exertion should be avoided to avoid aortic sinus or left ventricular perforation.
Aortic dissection or rupture is a fatal complication of TAVR. This complication can be reduced by accurate measurement of the size of the aortic annulus and avoidance of oversized balloon dilatation.
| Special Case Management|| |
Bicuspid aortic valve
There are multiple typing methods for the BAV. The more often used classification method is SIEVERS of 2007, which classifies BAV into TYPEs 0, 1, and 2. The most common congenital heart defect is BAV Type 0, 1 leaflet junctional fusion is Type 1, and 2 leaflets junctional fusion is Type 2. At present, the BAV calcified stenosis has not been included in the TAVR indication in Europe and America. However, more and more evidence shows that the efficacy of TAVR in BAV patients is not inferior to that in TAV patients.,,,, Compared with TAV patients, the disadvantages of TAVR in BAV patients include the following: (1) the annulus is elliptic, which causes the valve not to expand completely, which may affect long-term durability; (2) the native valve is not easy to fully expand, presenting a trapezoidal lobe shape, and the implant valve is easily squeezed downward to the ventricle by the native valve, resulting in the excessively deep implantation of the implant and the higher incidence of valve-in-valve implantation; (3) valve not highly calcified, asymmetric and different sized leaflets are prone to causing residual perivalvular leakage; and (4) the ascending aorta dilatation may be at risk of dissection in the long term. According to the current domestic experience, valve selection for BAV patients depends more on the supra-annulus structures. The circumference, diameter, and area of the annulus are for reference only. Appropriate balloon dilatation is selected according to the circumference of the annulus. Intraoperative dilatation is performed, and the valve size can be chosen on the basis of the diameter of balloon dilation. The self-expanding valve is generally released from a higher starting position (0–2 mm depth).
Surgical aortic bioprosthetic valve degeneration
There is a higher risk of secondary surgical valvular replacement when surgical bioprosthetic valve degeneration occurs. The valve-in-valve technique of TAVR provides an option for such patients. The operation skills and key points are as follows: (1) define the type and size of the surgical biological valve before surgery, verify with the MSCT results, and select the right valve; (2) understand the X-ray imaging characteristics of the lesion valve as a reference for the depth of the valve placement (note that some of the annulus shown on X-ray are not the lowest point of the valve stent); (3) understand the types of valvular disease (such as stenosis, regurgitation, or both); balloon pre-dilatation is not suggested with mainly AR to reduce the probability of stroke; (4) some patients have a smaller inner diameter of the surgical bioprosthetic valve annulus (such as 19 mm). Aortic valvular pressure gradient may be high due to left ventricular outflow tract obstruction or patient-prosthesis mismatch rather than valve stenosis. We should observe the motion of the leaflets and carefully identify. When the MSCT-measured inner diameter of the bioprosthetic prosthesis annulus is <17 mm, caution should be taken.
No calcification or mild calcification
Current studies have shown that TAVR is safe and effective for AS with no calcification and mild calcification., Rheumatism is the most common cause of noncalcified AS. Because of no calcification or mild calcification, the valve is easy to shift after release. Therefore, a larger valve size tends to be selected, and balloon pre- or post-dilatation is less frequently performed. The probability of performing valve-in-valve implantation is higher.
Poor vascular access
At present, the femoral artery valve delivery system in China is 18 F or above and generally requires the femoral artery's narrowest diameter to be >6.0 mm. When femoral artery access is poor, with severe stenosis or calcification (non-circular), the sheathless technique can be used to reduce the requirement of diameter of the blood vessels to 4.5 mm. If the sheathless technique is not feasible or there is still a great risk, other approaches such as the carotid artery, subclavian artery, ascending aorta, and apex of the heart can be selected according to the actual situation of each case.
As there is a large angle between the horizontal aorta and the annulus plane, it is difficult for the valves to pass. The delivery system is not coaxial with the aorta at the same time. After the valve stent is released, the lower edge is not parallel to the annulus plane under X-ray, which makes it difficult to locate the valve when it is released. The valve can easily be placed too deep after it is released completely, leading to the probability of perivalvular leakage, conduction block, and mitral valve function. The required operative skills and precautions are as follows: (1) when it is difficult to cross the delivery system through the aortic orifice, a snare can be used to assist, especially if a second valve is required due to severe perivalvular leakage; (2) the second-generation prosthetic valve system with retrievable function can be used, allowing the valve position to be repositioned when it is not ideal; and (3) the novel generation of adjustable bending delivery systems can help solve this problem.
Low coronary artery ostia
Preoperative and intraoperative evaluation should be carefully conducted, and some preventive measures can be taken. Section 6.3 on coronary artery occlusion.
Aortic stenosis with extreme calcification of the valve
Such patients have extremely calcified valves and large calcified masses, which can easily lead to unfavorable situations such as difficulty in the valve crossing through the delivery system, the valve stent cannot be fully expanded, serious perivalvular leakage occurs and balloon postdilatation is needed. According to the results of balloon dilatation, we choose a smaller valve, and the starting position is higher when the self-expanding valve is released.
The use of contrast agents and hypoperfusion during TAVR can lead to acute kidney injury, which may affect patient prognosis. However, recent studies have shown that renal function improvement, is more common in patients with TAVR because of improved renal perfusion. Therefore, renal insufficiency (including uremia) is not a contraindication for TAVR patients. During operation, minimal contrast agents should be used to avoid prolonged hypoperfusion. Hemodialysis may be performed after the operation if necessary.
Coronary heart disease
About 15%–80% of patients undergoing TAVR have coronary heart disease, and the higher the STS score, the higher the incidence. However, the observational study did not confirm the benefits of percutaneous coronary intervention (PCI) for patients with coronary heart disease. At present, guidelines and clinical practice still recommend PCI before TAVR in patients with proximal coronary artery stenosis of >70%. A number of studies have shown that PCI before or contemporaneously with TAVR is feasible and has similar results. However, PCI risk is significantly increased for patients with a left ventricular ejection fraction <30% or STS score >10%. It is recommended to choose concurrent PCI with TAVR and intraoperative aortic valve balloon dilation could be done to improve hemodynamics before PCI.
Emergency transcatheter aortic valve replacement
Some patients arrive in a critical condition, with severe heart failure or hemodynamic instability, unable to schedule TAVR and requiring emergency (within 24 h) TAVR. These patients are often unable to tolerate MSCT examination, such that preoperative evaluation is mainly dependent on echocardiography, especially three-dimensional echocardiography. Intraoperative angiography is used to evaluate the approach, and balloon dilatation is applied to assess the size of the annulus and risk of coronary artery blockage. Some patients with a particularly low ejection fraction (<25%) or unstable hemodynamics may receive preoperative and intraoperative circulatory support such as extracorporeal membrane oxygenation. In the absence of TAVR valves in the catheterization room, especially critical patients may undergo single aortic valve balloon dilatation first and then MSCT examination and evaluation until the condition is relatively stable, followed by selective TAVR.
In summary, compared with the Chinese expert consensus (2015 Edition) of TAVR, the Chinese expert consensus (updated version 2020) of TAVR has been updated as follows:
The epidemiological understanding was updated, and it was pointed out that the proportion of rheumatic etiology in Chinese patients with aortic valve disease was relatively high. Among the composition ratio of each anatomical subtype of the BAV patients, Type 0 (crest-free type) accounted for a higher proportion in Chinese patients than in Western countries.
The indications were updated. According to the latest clinical trial results, elderly age (≥70 years old) and low surgical risk were included in the relative indications. There was no specific age requirement for high-risk TAVR, and TAVR was the indication for patients with moderate risk and aged ≥70 years. Patients aged 60–70 years were judged to be suitable for TAVR by the cardiac team according to the risk of surgery and patient willingness.
The valve implantation procedure was updated, emphasizing that balloon predilatation can be used to assist in the selection of the artificial valve type and to predict the risk of valve blockage of the coronary artery. It was pointed out that the valve release process could be supplemented by rapid pacing to reduce the possibility of valve displacement.
Postoperative antithrombotic schemes were added. In general, after 3–6 months of dual antiplatelet therapy, lifelong single drug antiplatelet therapy was used. Patients with valve thrombosis and some with other anticoagulant indications should be treated with anticoagulant therapy alone.
The prevention and treatment of three important complications, including cardiac conduction block, coronary artery occlusion, and PVL, were described and updated in detail.
In special case management, three common clinical situations, including renal insufficiency, coronary heart disease, and emergency TAVR, were added.
Writing authors: Daxin Zhou (Zhongshan Hospital, Fudan University), Wenzhi Pan (Zhongshan Hospital, Fudan University), Yongjian Wu (Fuwai Hospital, Chinese Academy of Medical Sciences), Guangyuan Song (Fuwai Hospital, Chinese Academy of Medical Sciences).
Members of the core expert group (alphabetically by author's last name): Lianglong Chen (Union Hospital Affiliated to Fujian Medical University), Mao Chen (West China Hospital of Sichuan University), Junbo Ge (Zhongshan Hospital, Fudan University), Yong Huo (First Hospital of Peking University), Xiangqing Kong (People's Hospital of Jiangsu Province), Xianbao Liu (Second Hospital Affiliated to Zhejiang University Medical College), Jianfang Luo (People's Hospital of Guangdong Province), Zhiyuan Song (Southwest Hospital of Military Medical University), Xi Su (Wuhan Asian Heart Hospital), Ling Tao (Xijing Hospital of Air Force Military Medical University), Jian'an Wang (Second Affiliated Hospital of Zhejiang University Medical College), Yan Wang (Cardiovascular Hospital Affiliated to Xiamen University), Jian Yang (Xijing Hospital of Air Force Military Medical University), Haibo Zhang (Beijing Anzhen Hospital), Xianxian Zhao (Changhai Hospital of Naval Military Medical University), Yujie Zhou (Beijing Anzhen Hospital).
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, et al
. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis:First human case description. Circulation 2002;106:3006-8.
Holmes DR, Mack MJ, Kaul S, Agnihotri A, Alexander KP, Bailey SR, et al
. 2012 ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement. J Am Coll Cardiol 2012;59:1200-54.
Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP, Guyton RA, et al
. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: Executive summary: A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2014;63:2438-88.
Baumgartner H, Falk V, Bax JJ, Bonis MD, Hamm C, Holm PJ, et al
. 2017 ESC/EACTS guidelines for the management of valvular heart disease. Eur Heart J 2017;38:2739-91.
Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP, Fleisher LA, et al
. 2017 AHA/ACC focused update of the 2014 AHA/ACC guideline for the management of patients with valvular heart disease: A report of the American College of Cardiology/American Heart Association Task Force on clinical practice guidelines. J Am Coll Cardiol 2017;70:252-89.
Otto CM, Kumbhani DJ, Alexander KP, Calhoon JH, Desai MY, Kaul S, et al
. 2017 ACC expert consensus decision pathway for transcatheter aortic valve replacement in the management of adults with aortic stenosis: A report of the American College of Cardiology Task Force on clinical expert consensus documents. J Am Coll Cardiol 2017;69:1313-46.
Junbo G, Daxin Z, Wenzhi P, Zhen W, Lei G, Cuizhen P, et al
. Percutaneous aortic valve implantation: A case report. Chin J Int Cardiol 2010;18:243-6.
Chinese Medical Doctor Association Cardiovascular Medicine Division. structural heart disease Specialized Committee, structural cardiology branch of Chinese Medical Association cardiology branch. Chinese expert consensus on transcatheter aortic valve replacement. Chin J Int Cardiol 2015;23:661-7.
Otto CM, Lind BK, Kitzman DW, Gersh BJ, Siscovick DS. Association of aortic-valve sclerosis with cardiovascular mortality and morbidity in the elderly. N
Engl J Med 1999;341:142-7.
Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, ME Sarano, et al
. Burden of valvular heart diseases: A population-based study. Lancet 2006;368:1005-11.
Pan W, Zhou D, Cheng L, Shu X, Ge J. Candidates for transcatheter aortic valve implantation may be fewer in China. Int J Cardiol 2013;168:e133-4.
Jilaihawi H, Wu Y, Yang Y, Xu L, Chen M, Wang J, et al
. Morphological characteristics of severe aortic stenosis in China: Imaging corelab observations from the first Chinese transcatheter aortic valve trial. Catheter Cardiovasc Interv 2015;85 Suppl 1:752-61.
Pan W, Zhou D, Cheng L, Ge J.
Aortic regurgitation is more prevalent than aortic stenosis in Chinese elderly population: Implications for transcatheter aortic valve replacement. Int J Cardiol 2015;201:547-8.
Li Y, Wei X, Zhao Z, Liao Y, He J, Xiong T, et al
. Prevalence and complications of bicuspid aortic valve in Chinese according to echocardiographic database. Am J Cardiol 2017;120:287-91.
Hu P, Liu XB, Liang J, Zhu QF, Pu CX, Tang MY, et al
. A hospital-based survey of patients with severe valvular heart disease in China. Int J Cardiol; 2017;231:244-7.
Wenzhi P, Mingfei L, Daxin Z, Lihua G, Leilei C, Junbo G. et al
. Echocardiographic analysis of two leaflet aortic valve in patients with severe aortic stenosis. Chin J Cardiovascular Dis 2015;43:244-7.
Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, et al
. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N
Engl J Med 2019;380:1695-705.
Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, Hair DO, et al
. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N
Engl J Med 2019;380:1706-15.
Liu XB, Jiang JB, Zhou QJ, Pu ZX, He W, Dong AQ, et al
. Evaluation of the safety and efficacy of transcatheter aortic valve implantation in patients with a severe stenotic bicuspid aortic valve in a Chinese population. J Zhejiang Univ Sci B 2015;16:208-14.
Liao YB, Li YJ, Xiong TY, Ou YW, Lv WY, He JL, et al
. Comparison of procedural, clinical and valve performance results of transcatheter aortic valve replacement in patients with bicuspid versus tricuspid aortic stenosis. Int J Cardiol 2018;254:69-74.
Zhou D, Pan W, Wang J, Wu Y, Chen M, Modine T, et al
. Vita Flow™ transcatheter valve system in the treatment of severe aortic stenosis: One-year results of a multicenter study Catheter Cardiovasc Interv 2020;95:332-8.
Guangyuan S, Moyang W, Yuan W, Xianbao L, Yuan F, Xiangqing K, et al
. Effect of Venus-A aortic valve interventional therapy on severe aortic stenosis. Chin J Cardiovascular Dis 2017;45:843-7.
Liu H, Yang Y, Wang W, Zhu D, Wei L, Guo K, et al
. Transapical transcatheter aortic valve replacement for aortic regurgitation with a second-generation heart valve. J Thorac Cardiovasc Surg 2018;156:106-16.
Tchétché D, Chevalier B, Holzhey D, Harnath A, Schäfer U, Teiger E, et al
. TAVR for failed surgical aortic bioprostheses using a self-expanding device: 1-year results from the prospective VIVA postmarket study. JACC Cardiovasc Interv 2019;2:923-32.
Yoon SH, Schmidt T, Bleiziffer S, Schofer N, Fiorina C, Garcia AJ, et al
. Transcatheter aortic valve replacement in pure native aortic valve regurgitation. J Am Coll Cardiol 2017;70:2752-63.
Chinese Medical Doctor Association Cardiovascular Division, structural heart disease, Specialized Committee. Structural cardiology department, cardiology branch of Chinese Medical Association. Guidelines for team building and operation of transcatheter aortic valve replacement are recommended by Chinese experts. Chin J Interv Cardiol 2018;26:2-6.
Lauck SB, Sathananthan J, Park J, Achtem L, Smith A, Keegan P, et al
. Post-procedure protocol to facilitate next-day discharge: Results of the multidisciplinary, multimodality but minimalist TAVR study. Catheter Cardiovasc Interv 2019;94:1-9.
Hosoba S, Yamamoto M, Shioda K, Sago M, Koyama Y, Shimura T, et al
. Safety and efficacy of minimalist approach in transfemoral transcatheter aortic valve replacement: Insights from the Optimized trans Cath Eter vAlvular interventioN-Transcatheter Aortic Valve Implantation (OCEAN- TAVI) registry. Interact Cardiovasc Thorac Surg 2018;26:420-4.
Liu X, He Y, Zhu Q, Gao F, He W, Yu L, et al
. Supra-annular structure assessment for self-expanding transcatheter heart valve size selection in patients with bicuspid aortic valve. Catheter Cardiovasc Interv 2018;91:986-94.
Kappetein AP, Head SJ, Généreux P, Piazza N, Mieghem NM, Blackstone EH, et al
. Updated standardized endpoint definitions for transcatheter aortic valve implantation: The valve academic research consortium-2 consensus document. J Am Coll Cardiol; 2012:60:1438-54.
Auffret V, Puri R, Urena M, Chamandi C, Gabella TR, Philippon F, et al
. Conduction disturbances after transcatheter aortic valve replacement: Current status and future perspectives. Circulation 2017;136:1049-69.
Siontis GC, Jüni P, Pilgrim T, Stortecky S, Büllesfeld L, Meier B, et al
. Predictors of permanent pacemaker implantation in patients with severe aortic stenosis undergoing TAVR: A meta-analysis. J Am Coll Cardiol 2014;64:129-40.
Petronio AS, Sinning JM, van Mieghem N, Zucchelli G, Nickenig G, Bekeredjian R, et al
. Optimal implantation depth and adherenceto guidelines on permanent pacing to improve the results of transcatheter aortic valve replacement with the medtronic coreValve system: The CoreValve prospective. International, post-market ADVANCE-II study. JACC Cardiovasc Interv 2015;8:837-46.
Rodés-Cabau J, Ellenbogen KA, Krahn AD, Latib A, Mack M, Mittal S, et al
. Management of conduction disturbances associated with transcatheter aortic valve replacement: JACC Scientific Expert Panel. J Am Coll Cardiol 2019;74:1086-06.
Athappan G, Patvardhan E, Tuzcu EM, Svensson LG, Lemos PA, Fraccaro C, et al
. Incidence, predictors, and outcomes of aortic regurgitation after transcatheter aortic valve replacement: Meta-analysis and systematic review of literature. J Am Coll Cardiol 2013;61:1585-95.
Pibarot P, Hahn RT, Weissman NJ, Monaghan MJ. Assessment of paravalvular regurgitation following TAVR: A proposal of unifying grading scheme. JACC Cardiovasc Imaging 2015;8:340-60.
Ribeiro HB, Webb JG, Makkar RR, Cohen MG, Kapadia SR, Kodali S, et al
. Predictive factors, management, and clinical outcomes of coronary obstruction following transcatheter aortic valve implantation: Insights from a large multicenter registry. J Am Coll Cardiol 2013;62:1552-62.
Lansky AJ, Brown D, Pena C, Pietras CG, Parise H, Ng VG, et al
. Neurologic complications of unprotected transcatheter aortic valve implantation (from the Neuro- TAVI Trial. Am J Cardiol 2016;118:1519-26.
Davlouros PA, Mplani VC, Koniari I, Tsigkas G, Hahalis G
. Transcatheter aortic valve replacement and stroke: A comprehensive review. J Geriatr Cardiol 2018;15:95-104.
Haussig S, Mangner N, Dwyer MG, Lehmkuhl L, Lücke C, Woitek F, et al
. Effect of a cerebral protection device on brain Lesions following transcatheter aortic valve implantation in patients with severe aortic stenosis: The CLEAN-TAVI randomized clinical trial. JAMA 2016;316:592-601.
Ducrocq G, Francis F, Serfaty JM, Himbert D, Maury JM, Pasi N, et al
. Vascular complications of transfemoral aortic valve implantation with the Edwards SAPIEN prosthesis: Incidence and impact on outcome. Europ Interv 2010;5:666-72.
Holmes DR, Nishimura RA, Grover FL, Brindis RG, Carroll JD, Edwards FH, et al
. Annual outcomes with transcatheter valve therapy: From the STS/ACC TVT registry. J Am Coll Cardiol 2015;66:2813-23.
Landes U, Barsheshet A, Finkelstein A, Guetta V, Assali A, Halkin A, et al
. Temporal trends in transcatheter aortic valve implantation, 2008-2014: Patient characteristics, procedural issues, and clinical outcome. Clin Cardiol 2017;40:82-8.
Yoon SH, Bleiziffer S, De Backer O, Delgado V, Arai T, Ziegelmueller J, et al
. Outcomes in transcatheter aortic valve replacement for bicuspid versus tricuspid aortic valve stenosis. J Am Coll Cardiol 2017;69:2579-89.
Xiong TY, Feng Y, Liao YB, Li YJ, Zhao ZG, Wei X, et al
. Transcatheter aortic valve replacement in patients with non-calcific aortic stenosis. EuroIntervention 2018;13:e1756-63.
Jin QC, Pan WZ, Chen SS, Zhang XC, Zhang L, Zhou DX. Effects of transcatheter aortic valve replacement in patients with severe aortic valve stenosis. Zhonghua Xin Xue Guan Bing Za Zhi 2019;47:528-33.
Crowhurst JA, Savage M, Subban V, Incani A, Raffel OC, Poon K, et al
. Factors contributing to acute kidney injury and the impact on mortality in patients undergoing transcatheter aortic valve replacement. Heart Lung Circ 2016;25:282-9.
Lahoud R, Butzel DW, Parsee A, Huang YL, Solomon RJ, Devries JT, et al
. Acute kidney recovery in patients who underwent transcatheter versus surgical aortic valve replacement (from the Northern New England Cardiovascular Disease Study Group). Am J Cardiol 2020;125:788-94.
Azarbal A, Leadholm KL, Ashikaga T, Solomon RJ, Dauerman HL. Frequency and prognostic significance of acute kidney recovery in patients who underwent transcatheter aortic valve implantation. Am J Cardiol 2018;121:634-41.
Faroux L, Guimaraes L, Wintzer-Wehekind J, Vega LJ, Ferreira-Neto AN, Martín D, et al
. Coronary artery disease and transcatheter aortic valve replacement: JACC state-of- the-art review. J Am Coll Cardiol 2019;74:362-72.
Lateef N, Khan MS, Deo SV, Yamani N, Riaz H, Virk HUH, et al
. Meta-analysis comparing outcomes in patients undergoing transcatheter aortic valve implantation with versus without percutaneous coronary intervention. Am J Cardiol 2019;124:1757-64.
Goel SS, Ige M, Tuzcu EM, Ellis SG, Stewart WJ, Svensson LG, et al
. Severe aortic stenosis and coronary artery disease-implications for management in the transcatheter aortic valve replacement era: A comprehensive review. J Am Coll Cardiol 2013;62:1-10.
Yang L, Peng D, Liang C, Ping J, Jiayou T, Pengfei J, et al
. Extracorporeal membrane oxygenation assisted transcatheter aortic valve implantationTreatment of severe aortic stenosis with very low ejection fraction. Chin J Cardiopulmonary Bypass 2019;17:13-7.